QA/RA Specialist

QA/RA Specialist - Unity Partners - Vacatures

Unity Partners exclusively on behalf of our IVD/MedTech partner

Our partner is a specialist organisation in the IVD and medical device industry, developing innovative diagnostic products used by healthcare providers across approximately 80 countries. Operating in a highly regulated environment with a strong focus on quality and compliance, they are now looking to strengthen their QA/RA team with an experienced Senior QA/RA Specialist who can make an immediate impact.

As Senior QA/RA Specialist, you act as a subject matter expert and strategic partner within the organisation. You support product development, ensure regulatory compliance, lead audits and complex CAPAs, and actively contribute to continuous improvement of the QMS. You are someone who is not only strong on content, but also visible on the floor and effective in building relationships across departments.

This is a predominantly on-site role based in Ede.

Support product development, design transfer, and complex product changes

Interpret and apply regulatory requirements including IVDR across the organisation

Lead and assess complex CAPAs, including effectiveness checks and trend analyses

Prepare for, support, and participate in internal and external audits

Drive continuous improvement initiatives within the QMS

Coach and mentor junior and medior QA/RA colleagues

Provide strategic input on quality and compliance topics to internal stakeholders

Master's degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related field

4+ years of experience in QA/RA within the medical device or IVD industry

Strong knowledge of ISO 13485, IVDR, and audit practices

Experience with digital quality management systems; MasterControl experience is an advantage

Demonstrated ability to lead CAPAs and manage audits end-to-end

Comfortable working in an environment where QA/RA requires clear communication and the ability to navigate internal resistance

Able to operate independently and make an impact with minimal onboarding time

A key role in an innovative organisation with products that contribute directly to safer healthcare worldwide

Room for personal and professional development, including training budget and annual procedure updates

A direct and content-driven team with deep expertise in a complex regulatory environment

Part-time working (28 or 32 hours) is negotiable

Interested? Reach out to Christian Steenkamp via [staat bij de werkgever] | [staat bij de werkgever]

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